Kidney failure, heart problems, depression and addiction caused by products openly sold as herbal supplements are increasingly being reported by unsuspecting users around the country. Although marketing drugs in the guise of supplements is illegal in the United States, federal authorities are struggling with attempting to identify and intercept these hazardous black-market goods. Even though there is little evidence that so-called ‘dietary supplements’ provide any real health benefits, these products are a booming business in the United States and abroad.
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What’s the problem?
The huge market force at the center of the herbal supplement controversy makes the manufacturers of legal dietary products reluctant to voice their concerns. According to estimates from the Nutritional Business Journal, Americans spent nearly $30 billion on herbal supplements in 2010, up from around $21.3 billion in 2005.
Similar astronomical figures are being spent on black-market drugs marketed for weight loss, bodybuilding and sexual enhancement purposes. A large number of these products have been found to contain amphetamines, synthetic steroids, and compounds like the active ingredient found in Viagra. Federal health authorities have stated that such products can cause a number of adverse side effects including heart attacks, strokes, as well as significant kidney and liver damage. Sadly, there have even been a number of deaths conclusively linked to these dietary supplement products.
Supplement manufacturers insist that the vast majority of such products are safe, and claim that the problem stems from federal regulators failing to stop the influx of illegal products from overseas. “We walk a fine line,” says Steve Mister, president of the Council for Responsible Nutrition, a Washington trade group that represents supplement manufacturers and ingredient suppliers.“We want to protect consumers, but we also don’t want to alarm consumers so they stay away from the whole marketplace.”
According to the U.S. Food & Drug Administration (FDA), supplements are defined as products that contain only supplemental dietary ingredients such as vitamins and minerals. It is when these products are knowingly spiked with regulated drugs that a violation occurs. The Council for Responsible Nutrition recommends that consumers buy nationally recognized brands like Centrum, One A Day and Nature Made, and avoid products that make miracle claims. Mister says the problem is that federal regulators lack the resources to stop the import of illegal ingredients and finished products into the United States.
American supplement makers can introduce new products much more easily than pharmaceutical companies, who are required to obtain federal approval before going to market. Dietary supplements, on the other hand, do not require premarket approval, which makes it easier for manufacturers of spiked products to use the guise of herbal supplements to pedal their drugs.
As grim as the situation seems, the news is not all bad. According to Mister, safety measures in the legitimate industry have been steadily increasing. Over the past three years, new federal guidelines have been put into place requiring supplement manufacturers to test and certify each ingredient. Supplement companies are also now required to test finished goods to ensure that they match the ingredients on the label. Some reputable manufacturers have even gone a step further, hiring outside labs to independently test their products to certify that they are free of illegal contaminants.
For its part, the supplement industry argues that existing regulations work fine and that the FDA is at fault for failing to seize tainted goods and institute mandatory recalls. Mister says that reputable manufacturers are focused on their own products, rather than on warning the public about what other companies may be doing.
“We are concerned that if we alert consumers, we may unnecessarily drive them away from the marketplace,” he says. “We could make them afraid to take legitimate dietary supplements.”
But according to Daniel Fabricant, director of the F.D.A.’s division of dietary supplement programs, the supplement industry may be miscalculating. Fabricant believes the increased availability of tainted products represents a massive public health concern that could severely damage the dietary supplement industry as a whole in the near future.
“To my mind,” he says, “it’s the biggest issue we face.”
Do You Have an Herbal Supplement Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in herbal supplement lawsuits. We are handling individual litigation nationwide and currently accepting new dietary supplement injury cases in all 50 states.